BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER, IRRIGATION SOLUTION

    MDR report key: 5735170 · Received June 20, 2016

    Report

    Report Number
    5735170
    Event Type
    Malfunction
    Date Received
    June 20, 2016
    Date of Event
    October 7, 2015
    Report Date
    May 17, 2016
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WENT THROUGH ENTIRE CASE AND NOTICED AFTER THE PATIENT LEFT THE ROOM THAT THERE WAS ABOUT 1 CM OF IRRIGATION UNDERNEATH THE STERILE SLUSH DRAPE. CHECKED FOR LEAKS, BUT WAS UNABLE TO PIN POINT A LEAK LOCATION. DRAPE SAVED AND SENT TO COMPANY FOR TESTS TO BE COMPLETED. VERIFIED WITH SCRUB NURSE THAT THERE WERE NO BLUNT/SHARP OBJECTS PLACED IN THE STERILE DRAPE AT ANY TIME. SURGEON MADE AWARE VIA EMAIL BY RESOURCE NURSE. DRAPE INFORMATION: SLUSH/WARMER DISC-DRAPE, REF#ORS-320, LOT#D143431.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390379 WARMER, IRRIGATION SOLUTION LHC MEDICAL ACTION INDUSTRIES D143431

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR